SEGA - SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke - a Randomized Comparative Effectiveness Trial.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 260
- Locations
- 11
- Primary Endpoint
- Modified Ordinal Rankin Scale (mRS)
Study Overview
Brief Summary
Objectives:
This study aims to estimate overall treatment benefit (improvement in disability) among acute ischemic stroke patients that are randomized to General Anesthesia (GA) compared with Sedation (CS) during endovascular therapy. Assess safety (as measured by incidence of symptomatic intracranial hemorrhage); rates of Endovascular therapy (EVT) procedural complications, reperfusion; and quality of life.
Hypothesis:
GA during EVT for acute ischemic stroke improves functional outcomes at 90 days compared to sedation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Acute ischemic stroke due to large intracranial vessel occlusion demonstrated on CT-angiography in the following anterior circulation locations that will be treated by endovascular therapy (EVT):
- •Internal Carotid Artery (terminal "T" or "L-type"- occlusion)
- •Middle Cerebral Artery (MCA) M1 or proximal M2
- •Anterior Cerebral Artery (ACA) A1 or proximal A2
- •Patients who receive IV-tPA thrombolysis are eligible provided the drug was delivered within 4.5 hours of stroke onset or last seen normal and in accordance with local hospital standard of care.
- •National Institute of Health Stroke Scale (NIHSS) score 6-30
- •Time of from stroke symptom onset of last seen normal to start of EVT (defined as groin puncture) ≤ 16 hours.
- •Limited infarct core, as defined below and adapted from the 2018 American Heart Association guidelines
- •For patients presenting ≤ 6 hours from time of symptom onset or last seen normal, Alberta Stroke Program Early Computed Tomography Score (ASPECTS) ≥ 6
- •For patients presenting > 6 hours and ≤ 16 hours from time of symptom onset or last seen normal, they must satisfy EITHER ONE of the two following criteria:
- •i. Ischemic core by CT Perfusion or MRI/MR Perfusion < 70 mL, a ratio of volume of penumbral tissue to infarct core of ≥ 1.8, and and absolute volume of penumbral tissue of ≥ 15 mL OR ii. For patients with NIHSS ≥ 10, infarct core of < 31 mL by CT Perfusion or MRI; For patients with NIHSS ≥ 20, infarct core < 51 mL.
- •Subject willing/able to return for protocol required follow up visits.
- •No significant pre-stroke disability (modified Rankin Score must be ≤ 2).
- •Females of childbearing potential must have a negative serum or urine pregnancy test.
- •Patient or patient's legally authorized representative has given Informed Consent according to Good Clinical Practices (GCP) and/or local IRB policies.
Exclusion Criteria
- •Coma on admission (Glasgow Coma Scale <8), need for intubation upon ED arrival, or transferred patients who present previously intubated.
- •Severe agitation or seizures on admission that preclude safe vascular access.
- •Loss of airway protective reflexes and/or vomiting on admission.
- •Predicted or known difficult airway.
- •Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia.
- •Presumed septic embolus, or suspicion of bacterial endocarditis
- •Currently participating or has participated in any investigational drug or device study within 30 days.
- •Inability to follow-up for 90-day assessment.
- •Known history of allergy to anesthesia drugs.
- •Known history or family history of malignant hyperthermia
Arms & Interventions
Sedation
The protocol does not specify a particular combination of drugs that must be used for sedation. The choice of specific drugs and dosages for achieving sedation will be up to the anesthesiologist.
Intervention: Sedation (Drug)
Sedation
The protocol does not specify a particular combination of drugs that must be used for sedation. The choice of specific drugs and dosages for achieving sedation will be up to the anesthesiologist.
Intervention: Intra-arterial Thrombectomy (Procedure)
General Anesthesia
The protocol does not specify a particular combination of drugs that must be used for general anesthesia. The choice of specific drugs and dosages for achieving general anesthesia will be up to the anesthesiologist.
Intervention: General Anesthesia (GA) (Drug)
General Anesthesia
The protocol does not specify a particular combination of drugs that must be used for general anesthesia. The choice of specific drugs and dosages for achieving general anesthesia will be up to the anesthesiologist.
Intervention: Intra-arterial Thrombectomy (Procedure)
Outcomes
Primary Outcomes
Modified Ordinal Rankin Scale (mRS)
Time Frame: 90 days
mRS ranges from 0 to 6, with higher scores indicating greater disability. 6 categories are reported: number of participants who had a score of 0, 1, 2, 3, or 4 will be reported separately as 5 categories, and those who had a score of 5 or 6 will be combined and reported as a single category. 0: no symptoms/normal (physical, cognitive etc.) 1. no significant disability despite symptoms; able to carry out all usual duties and activities 2. slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. moderate disability; requiring some help, but able to walk without assistance from another individual (use of walking aids alone is not counted as assistance) 4. moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. dead
Secondary Outcomes
- Dichotomized Modified Ordinal Rankin Scale (mRS)(90 days)
- Number of Participants With Angiographic Reperfusion Defined as Modified a TICI Score of ≥ 2b(post procedure within 6 hours)
- Score on the National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS)(24-36 hours post procedure)
- Number of Participants With Functional Independence as Indicated by an mRS Score of 0, 1, or 2(90 days)
- Quality of Life as Assessed by the European Quality of Life (EuroQol) 5 Dimensions 5 Level Version (EQ-5D-5L) Assessment(90 days)
- Number of Participants With Symptomatic Intracerebral Hemorrhage(18-36 hours post procedure)
- Number of Participants With All-cause Mortality(18-36 hours post procedure)
- Number of Participants With Procedural Complications(18-36 hours post procedure)
Investigators
Peng Roc Chen, MD
Professor in Neurosurgery
The University of Texas Health Science Center, Houston